On June 10, the Food and Drug Administration (FDA) told US citizens to stop using the Innova SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic use and “place them in the trash”.
The regulator had concerns “that the performance of the test has not been adequately established, presenting a risk to health” and some of the manufacturer’s labels contained “performance claims” that “did not accurately reflect the performance estimates observed during the clinical studies of the tests”.
The FDA ultimately decided to recall the tests in the US as they had not been previously cleared for use in that country.
A spokesperson for Innova told C+D: “The regulator won’t confirm a product is safe to use until it has evaluated and authorised a product itself.”
The manufacturer understands the FDA’s concerns as its product has not yet been approved for use in the US, but “there is absolutely no link between the FDA’s letter regarding the process for authorisation in the US and the Innova products in the UK”, the spokesperson stressed yesterday (June 14).
“We have robust data proving the quality of the product in many other jurisdictions, with the largest data set from the UK,” they added, and stressed that none of the FDA's "inspectional observations" are to do with the test's performance.
See the Department of Health and Social Care's (DH) stance on how the FDA's decision will effect the Pharmacy Collect service here.
To date, the FDA has not received reports of injuries or death associated with the use of the Innova SARS-CoV-2 Antigen Rapid Qualitative Test, the US regulator said on its website.
New UK data shows high specificity of Innova tests
The Innova tests are distributed under different names, including Innova SARS-CoV-2-Antigen Rapid Qualitative Test (7T configuration) – which participating community pharmacies in England and Scotland can order from Alliance Healthcare and Sigma Pharmaceuticals (PIP: 8943037).
In a letter to Innova last week, the FDA said of the 7T and 25T configuration tests that their labelling was “false or misleading” as the clinical performance estimates “do not accurately reflect the performance estimates observed during the clinical studies of your devices.”.
A DH spokesperson told C+D yesterday that the “Innova test has already gone through the UK’s rigorous Porton Down assessment process, and we have a robust quality assurance process in place”.
In March, the DH published further analysis of data collected during phase 4 of the Porton Down and Oxford University study, which evaluated the performance of the Innova tests against polymerase-chain-reaction (PCR) tests.
The analysis showed that the Innova tests have “a specificity of at least 99.9% when used to test in the community”, which means “fewer than one false positive in every 1,000 lateral flow tests carried out”.
Asymptomatic NHS staff started using the Innova tests last year
No change to Pharmacy Collect
Pharmacies in England quickly started distributing COVID-19 lateral flow test kits after the Pharmacy Collect service was launched on March 29 – more than nine in 10 pharmacies were already offering the service as of April 19.
The service also launched in Scotland last week (June 7).
C+D asked the DH whether it will continue to commission the service in light of the FDA’s advice. A spokesperson said there is “no change” to the service at the moment.
The DH believes that lateral flow tests will help detect COVID-19 cases quickly as restrictions ease.
Source: UK Parliament, written questions, answers and statements